FDA Inspection
Techni Med, Inc. dba The CompounderTechni Med, Inc. dba The Compounder – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Techni Med, Inc. dba The Compounder, with an inspection on January 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Bryan L. Mcguckin
- Emilie Kahn (Issuing Officer)
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ID · 8235b635-187e-411d-8004-7da0e10888dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1041122
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
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Other FDA inspections of Techni Med, Inc. dba The Compounder
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 9, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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