GORAN PHARMA PRIVATE LIMITED
Form 483 issued November 15, 2017 · Sihor, India
- Inspection
- Nov 13 – Nov 15, 2017
- Investigator
- Cheryl Clausen
- Observations
- 17
- Pages
- 11
- FEI number
- 3009336980
In short: On November 15, 2017, FDA issued a Form 483 with 17 observations to GORAN PHARMA PRIVATE LIMITED in Sihor, Gujarat (FEI 3009336980) after an inspection that ran Nov 13 – Nov 15, 2017. The investigator was Cheryl Clausen. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Adequate lab facilities for testing and approval or rejection of components and drug products are not…
- 02
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Written procedures are not established for evaluations done at least annually and including provisions for a…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmGORAN PHARMA PRIVATE LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GORAN PHARMA PRIVATE LIMITED?
FDA listed 17 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected GORAN PHARMA PRIVATE LIMITED?
Cheryl Clausen is named on this Form 483, for the inspection of Nov 13 – Nov 15, 2017. Each investigator has a profile showing what they cite most.
When was GORAN PHARMA PRIVATE LIMITED inspected by FDA?
The inspection ran Nov 13 – Nov 15, 2017, and the Form 483 is dated November 15, 2017.
How do I get the full Form 483 for GORAN PHARMA PRIVATE LIMITED?
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.