FDA Inspection
Destileria Serralles, Inc.Destileria Serralles, Inc. – FDA Inspection, Aug 9, 2016
Record Details
This FDA Inspection record concerns Destileria Serralles, Inc., with an inspection on August 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Destileria Serralles, Inc.
- Inspection Date
- August 9, 2016
- Product Type
- Drugs
View Company Profile
ID · 94b12101-1966-4efe-8753-05d9fe37de0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982470
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Destileria Serralles, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Destileria Serralles, Inc.
- FDA Inspection 1136526 - 2021-03-11
- FDA Inspection 959771 - 2016-01-27
- FDA Inspection 635576 - 2009-12-16
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