FDA Inspection
Destileria Serralles, Inc.Destileria Serralles, Inc. – FDA Inspection, Mar 11, 2021
Record Details
This FDA Inspection record concerns Destileria Serralles, Inc., with an inspection on March 11, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Destileria Serralles, Inc.
- Inspection Date
- March 11, 2021
- Product Type
- Drugs
View Company Profile
ID · 83d38eaf-9a56-4cc3-95ce-500dba9499d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1136526
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 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 211.25(a)GMP Training Frequency
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Destileria Serralles, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2016 | 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 982470 - 2016-08-09
- FDA Inspection 959771 - 2016-01-27
- FDA Inspection 635576 - 2009-12-16
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