Symbiotec Pharmalab Private Limited
Form 483 issued May 5, 2017 · Pithampur, India
- Inspection
- May 1 – May 5, 2017
- Investigator
- Satheesh Thomas
- Observations
- 6
- Pages
- 5
- FEI number
- 3009298759
In short: On May 5, 2017, FDA issued a Form 483 with 6 observations to Symbiotec Pharmalab Private Limited in Pithampur, M.P (FEI 3009298759) after an inspection that ran May 1 – May 5, 2017. The investigator was Satheesh Thomas. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records associated with drug substance, components, containers, closures, labeling, production, control laboratory analysis and distribution within…
- 02
Employees, who had performed GMP related work at your site per related GMP documents, were…
- 03
The stability program for an API does not include…
- 0421 CFR 11
A full risk assessment of your firm’s computer system validation, to demonstrate your firm’s 21 CFR…
This inspection in context
Satheesh Thomas
3 documents · 2015–2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSymbiotec Pharmalab Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symbiotec Pharmalab Private Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Symbiotec Pharmalab Private Limited?
Satheesh Thomas is named on this Form 483, for the inspection of May 1 – May 5, 2017. Each investigator has a profile showing what they cite most.
When was Symbiotec Pharmalab Private Limited inspected by FDA?
The inspection ran May 1 – May 5, 2017, and the Form 483 is dated May 5, 2017.
How do I get the full Form 483 for Symbiotec Pharmalab 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.