FDA Inspection
Mytilini Enterprises LLC dba Bedford Pharmacy Inc.Mytilini Enterprises LLC dba Bedford Pharmacy Inc. – FDA Inspection, Aug 17, 2017
Record Details
This FDA Inspection record concerns Mytilini Enterprises LLC dba Bedford Pharmacy Inc., with an inspection on August 17, 2017, issued by the New England District Office, covering human drugs.
- Inspection Date
- August 17, 2017
- Product Type
- Human Drugs
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ID · 03454b52-4c59-4394-8d40-8459342d8e95
Inspection Facts
- Inspection number
- 1023294
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
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Other FDA inspections of Mytilini Enterprises LLC dba Bedford Pharmacy Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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