Prescript Pharmaceuticals, Inc — FDA Facility Profile
Prescript Pharmaceuticals, Inc is an FDA-registered facility (FEI 1000135824) located in Pleasanton, CA, US. Registered operations: RELABEL; REPACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 7, 2025: No Action Indicated (NAI)
- Inspections on record
- 6 (1 OAI, 4 VAI, 1 NAI)
- Last OAI inspection
- Mar 3, 2011
- 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
- 1, latest Apr 24, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 7, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 30, 2018 | Voluntary Action Indicated (VAI) | Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Quality control unit review of records (21 CFR 211.192) Storage under appropriate conditions (21 CFR 211.142(b)) Items to cover on annual reviews (21 CFR 211.180(e)(2)) |
| Mar 25, 2014 | Voluntary Action Indicated (VAI) | Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Lack of written stability program (21 CFR 211.166(a)) Quality control unit review of records (21 CFR 211.192) Drug product reserve containers (21 CFR 211.170(b)) and 1 more |
| Nov 16, 2011 | Voluntary Action Indicated (VAI) | input/output verification (21 CFR 211.68(b)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Lack of written stability program (21 CFR 211.166(a)) Drug product reserve containers (21 CFR 211.170(b)) and 2 more |
| Mar 3, 2011 | Official Action Indicated (OAI) | No citations listed |
| Jul 21, 2009 | Voluntary Action Indicated (VAI) | Adequate ventilation not provided (21 CFR 211.46(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 24, 2018 | Class II | D-0805-2018 | Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc… and 4 more products Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original… |
Facility details
- Company
- Prescript Pharmaceuticals, Inc.
- Location
- Pleasanton, CA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- RELABEL; REPACK
- Source
- decrs