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Professional Compounding Centers Of America FDA Record

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

Latest inspection VAI · Apr 21, 2023
Last warning letter 2021

Inspections 6

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jan 7, 2021

510(k) clearances 0 None on file

Professional Compounding Centers Of America has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Professional Compounding Centers Of America, the most recent on Jan 7, 2021.

What these totals cover: FDA records filed under the name "Professional Compounding Centers Of America".

Latest inspection: Apr 21, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	6	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

Professional Compounding Centers Of America's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Professional Compounding Centers Of America: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	1	0	0
2022	0	0	0
2021	0	0	1
2020	0	0	0
2019	2	1	0
2018	0	0	0
2017	1	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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Professional Compounding Centers Of America FDA Warning Letters

1 warning letter on Jan 7, 2021.

Issued	Subject	Issuing office	Close-out letter
Jan 7, 2021 · 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.

Recent FDA inspections

6 inspections from Jun 11, 2009 to Apr 21, 2023.

Date	Site	Product	Classification	FEI
Apr 21, 2023	Houston, TX	Drugs	Voluntary Action Indicated (VAI)	1629694
Oct 29, 2019	Houston, TX	Drugs	Official Action Indicated (OAI)	1629694
Mar 4, 2019	Houston, TX	Drugs	No Action Indicated (NAI)	1629694
Feb 23, 2017	Houston, TX	Drugs	Voluntary Action Indicated (VAI)	1629694
Mar 14, 2012	Houston, TX	Drugs	No Action Indicated (NAI)	1629694
Jun 11, 2009	Houston, TX	Drugs	Official Action Indicated (OAI)	1629694

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 Professional Compounding Centers Of America: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 7, 2021.

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 1629694	Houston, TX	6	Apr 21, 2023

Professional Compounding Centers Of America and the FDA: common questions

Has Professional Compounding Centers Of America received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Professional Compounding Centers Of America. The most recent is dated Jan 7, 2021.

Has Professional Compounding Centers Of America received an FDA Form 483?

FDA has not published a Form 483 for "Professional Compounding Centers Of America" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Professional Compounding Centers Of America?

The most recent FDA inspection on file ended Apr 21, 2023 at Houston, TX and was classified VAI. FDA has 6 inspections of Professional Compounding Centers Of America on file, 2 of them classified OAI (official action indicated).

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