FDA Inspection
Advanced Cosmetic Research Laboratories, Inc.Advanced Cosmetic Research Laboratories, Inc. – FDA Inspection, Jul 24, 2023
Record Details
This FDA Inspection record concerns Advanced Cosmetic Research Laboratories, Inc., with an inspection on July 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ac1fafe1-495d-498a-bc21-4d6d34198dec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1211197
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Advanced Cosmetic Research Laboratories, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| April 27, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 1, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Advanced Cosmetic Research Laboratories, Inc.
- FDA Inspection 1258735 - 2025-01-17
- FDA Inspection 1168356 - 2022-04-27
- FDA Inspection 1145184 - 2021-06-07
- FDA Inspection 979072 - 2016-06-03
- FDA Inspection 737214 - 2011-08-01
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