FDA Inspection
Pharmco Laboratories Inc.Pharmco Laboratories Inc. – FDA Inspection, Sep 22, 2021
Record Details
This FDA Inspection record concerns Pharmco Laboratories Inc., with an inspection on September 22, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmco Laboratories Inc.
- Inspection Date
- September 22, 2021
- Product Type
- Drugs
View Company Profile
ID · 81c6dcd9-f49b-43b0-a44e-5c4d59125118
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152419
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pharmco Laboratories Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| June 28, 2019 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 30, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmco Laboratories Inc.
- FDA Inspection 1231002 - 2025-03-20
- FDA Inspection 1096135 - 2019-06-28
- FDA Inspection 951092 - 2015-11-30
- FDA Inspection 787476 - 2012-06-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.