FDA Inspection
Pacifico National, Inc. dba AmEx PharmacyPacifico National, Inc. dba AmEx Pharmacy – FDA Inspection, May 31, 2019
Record Details
This FDA Inspection record concerns Pacifico National, Inc. dba AmEx Pharmacy, with an inspection on May 31, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 18e59170-0322-4272-9338-c5513f5eef78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091321
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Sample Record
FDA Citations
13- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pacifico National, Inc. dba AmEx Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pacifico National, Inc. dba AmEx Pharmacy
- FDA Inspection 957266 - 2016-01-21
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.