College Pharmacy Incorporated
Form 483 issued January 17, 2018 · Colorado Springs, Colorado
- Inspection
- Jan 8 – Jan 17, 2018
- Investigators
- Haroon Vohra· Marcus F. Yambot
- Observations
- 6
- Pages
- 5
- FEI number
- 1000117234
In short: On January 17, 2018, FDA issued a Form 483 with 6 observations to College Pharmacy Incorporated in Colorado Springs, Colorado (FEI 1000117234) after an inspection that ran Jan 8 – Jan 17, 2018. The investigators were Haroon Vohra and Marcus F. Yambot.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02FDCA 501(a)(2)(A)
You produced highly potent chugs without providing adequate cleaning of work surfaces and cleaning of…
- 03FDCA 501(a)(2)(A)
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 04FDCA 501(a)(2)(A)
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Haroon Vohra
3 documents · 2017–2020
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmCollege Pharmacy Incorporated history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at College Pharmacy Incorporated?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected College Pharmacy Incorporated?
Haroon Vohra and Marcus F. Yambot are named on this Form 483, for the inspection of Jan 8 – Jan 17, 2018. Each investigator has a profile showing what they cite most.
When was College Pharmacy Incorporated inspected by FDA?
The inspection ran Jan 8 – Jan 17, 2018, and the Form 483 is dated January 17, 2018.
How do I get the full Form 483 for College Pharmacy Incorporated?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.