P & L Development, LLC FDA Inspection Record
P & L Development, LLC is an FDA-registered facility (FEI 1000306997) located in westbury, NY, US. Registered operations: RELABEL; REPACK. RegDataLab tracks 13 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 23, 2025: No Action Indicated (NAI)
- Inspections on record
- 13 (4 VAI, 9 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 4, latest Sep 9, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 23, 2025 | No Action Indicated (NAI) | No citations listed |
| Dec 31, 2024 | No Action Indicated (NAI) | No citations listed |
| Aug 16, 2023 | No Action Indicated (NAI) | No citations listed |
| Nov 18, 2021 | No Action Indicated (NAI) | No citations listed |
| Feb 6, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 13, 2018 | Voluntary Action Indicated (VAI) | Packaging line inspection before use (21 CFR 211.130(e)) Identification of Person Performing Review of Lab Records (21 CFR 211.194(a)(8)) |
| Sep 27, 2018 | No Action Indicated (NAI) | No citations listed |
| Sep 17, 2014 | Voluntary Action Indicated (VAI) | Investigations of discrepancies, failures (21 CFR 211.192) Written warehousing procedures established/followed (21 CFR 211.142) |
| Aug 24, 2012 | Voluntary Action Indicated (VAI) | Written procedures not established/followed (21 CFR 211.67(b)) |
| Aug 10, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 9, 2020 | Class III | D-0004-2021 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton… Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not… |
| Jun 5, 2019 | Class II | D-1407-2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten… and 2 more products cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they… |
| Apr 17, 2017 | Class III | D-0694-2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels… Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. |
| Mar 22, 2010 | Class II | D-595-2010 | Ketotifen Ophthalmic Solution Eye Drops , 5 mL (0.17 FL OZ) Bottle, Sterile, OTC. The… Failed PH Specifications: out of specification (OOS) results for pH during stability testing |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- P & L Development, LLC
- Location
- westbury, NY (US)
- Registration Expires
- Dec 31, 2026
- Operations
- RELABEL; REPACK
- Source
- decrs