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People's Custom Rx And Clinical Care, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Aug 5, 2021
1 Class I recall
Last warning letter 2016

Inspections 4

2 OAI

Recalls 1

1 Class I (100%)

Warning letters 1 Latest Jun 6, 2016

510(k) clearances 0 None on file

People's Custom Rx And Clinical Care, LLC has 1 FDA recall (1 Class I), 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to People's Custom Rx And Clinical Care, LLC, the most recent on Jun 6, 2016. FDA has published 5 Form 483s for People's Custom Rx And Clinical Care, LLC.

What these totals cover: FDA records filed under the name "People's Custom Rx And Clinical Care, LLC" and its spelling variant "People Custom Rx And Clinical Care".

Latest recall: D-0718-2021 · Class I · May 11, 2021
Latest inspection: Aug 5, 2021 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1 (1 Class I)	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

People's Custom Rx And Clinical Care, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

People's Custom Rx And Clinical Care, LLC: FDA inspections per year

Year	Inspections	OAI	Recall records	Class I
2026	0	0	0	0
2025	0	0	0	0
2024	0	0	0	0
2023	0	0	0	0
2022	0	0	0	0
2021	1	0	1	1
2020	0	0	0	0
2019	1	0	0	0
2018	1	1	0	0
2017	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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People's Custom Rx And Clinical Care, LLC FDA Warning Letters

1 warning letter on Jun 6, 2016.

Issued	Subject	Issuing office	Close-out letter
Jun 6, 2016 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

People's Custom Rx And Clinical Care, LLC Form 483s

5 Form 483s published by FDA.

Date	Document	FEI
Jan 18, 2024 · Document on fda.gov	483
Aug 5, 2021 · Document on fda.gov	483	3003780900
Jul 24, 2019 · Document on fda.gov	483	3003780900
Jul 20, 2018 · Document on fda.gov	483	3003780900
Oct 6, 2015 · Document on fda.gov	483	3003780900

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent recalls

1 recall record on May 11, 2021.

Number	Class	Product	Date
D-0718-2021	Class I	C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only…	May 11, 2021

Recent FDA inspections

4 inspections from Jul 29, 2015 to Aug 5, 2021.

Date	Site	Product	Classification	FEI
Aug 5, 2021	Memphis, TN	Drugs	Voluntary Action Indicated (VAI)	3003780900
Jul 24, 2019	Memphis, TN	Drugs	Voluntary Action Indicated (VAI)	3003780900
Jul 2, 2018	Memphis, TN	Drugs	Official Action Indicated (OAI)	3003780900
Jul 29, 2015	Memphis, TN	Drugs	Official Action Indicated (OAI)	3003780900

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under People's Custom Rx And Clinical Care, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 6, 2016.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003780900	Memphis, TN	4	Aug 5, 2021

People's Custom Rx And Clinical Care, LLC and the FDA: common questions

Has People's Custom Rx And Clinical Care, LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to People's Custom Rx And Clinical Care, LLC. The most recent is dated Jun 6, 2016.

Has People's Custom Rx And Clinical Care, LLC received an FDA Form 483?

FDA has published 5 Form 483s for People's Custom Rx And Clinical Care, LLC in its reading room, the most recent dated Jan 18, 2024. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect People's Custom Rx And Clinical Care, LLC?

The most recent FDA inspection on file ended Aug 5, 2021 at Memphis, TN and was classified VAI. FDA has 4 inspections of People's Custom Rx And Clinical Care, LLC on file, 2 of them classified OAI (official action indicated).

Has People's Custom Rx And Clinical Care, LLC had an FDA recall?

Yes. People's Custom Rx And Clinical Care, LLC has 1 FDA recall on record, 1 of them Class I, the most serious class. The most recent started May 11, 2021.

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