Dasami Lab Private Limited
Form 483 issued June 1, 2018 · Nalgonda, India
- Observations
- 4
- Pages
- 2
- FEI number
- 3012753303
In short: On June 1, 2018, FDA issued a Form 483 with 4 observations to Dasami Lab Private Limited in Nalgonda, Telangana (FEI 3012753303). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 3 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
JY our firm does not have the stability data to support the!" retest date given to…
- 02
Your firm did not start using the equipment log books for the analytical balances…
- 03
Your analytical method transfers and method verifications are inadequate. Specially, A. Your firm does not have…
- 04
Your procedure for handling power failure, SOP 15-029-00, “Power Failure”, effective…
This inspection in context
Questions about this 483
What did FDA find at Dasami Lab Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Dasami Lab Private Limited inspected by FDA?
This Form 483 is dated June 1, 2018.
How do I get the full Form 483 for Dasami Lab 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.