GMP News, GMP guidelines, GMP Violations, GMP warnings A Public Health Global News Portal

Welcome to gmpviolations.com FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters..

150000+ Industry Leaders already read it everyday

Tuesday, March 20, 2018

CIPLA gets 483 by U.S. FDA For Goa Unit | CIPLA 483 | FDA |













Cipla Ltd. received eight observations regarding manufacturing practices at its Goa plant that contributes a quarter of the drugmaker’s sales in the U.S.
The facility of India’s second-largest pharma company by market value was inspected from Jan. 22 -25, according to a Form 483 issued by the U.S. Food and Drug Administration.

Here are the eight U.S. FDA observations for the Goa plant:
  • Failure to review out of specification investigation.
  • Failure of documentation of batch production and control records.
  • Laboratory records incomplete of all data obtained during testing.
  • Establishment test procedures are not followed.
  • No visual examination of reserve samples lots.
  • Appropriate lab determination of drugs missing.
  • Quality control procedures are not in writing and fully followed.
  • Equipment not of appropriate design.
The first observation is a repeat and a little concerning while the others are procedural, said Praful Bohra of brokerage Equirus Capital. Cipla will have to explain to the U.S. FDA the difference in the conclusion tests for the plant to get cleared, he said.

Source: BloombergQuint



www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.
Share:

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

AMAZON BEST DEALS

Popular Posts

AMAZON BEST DEALS

Subscribe Free GMP Guidelines

Enter your email address:

Delivered by FeedBurner

Followers

Printfriendly

Subscribe via email for free

Services

Enter your email address:

Delivered by FeedBurner

Contact Form

Name

Email *

Message *

Menu :
Powered by Blogger.

Visitors

    Translater

    Related Posts Plugin for WordPress, Blogger...

    Category

    2016 (37) 2017 (85) 2018 (9) 211 CFR (1) 211.63 (1) 483 (5) AAFA (1) Abbott (2) AboutUs (1) ALCOA (1) Alerts (2) ANDA (1) Anshu (2) Antibiotics (1) apic (1) APR17 (8) APS (2) Articles (4) AstraZeneca (1) Aug17 (2) Aurobindo (2) Author (2) Authors (8) Biocon (1) cadila (1) capa (3) CDSCO (5) Change control (1) Christian Green (1) cipla (2) Cleaning validation (1) Data Integrity (9) dec16 (15) Definations (1) Deviations (1) Donald Trump’s (2) Downloads (17) Dr.Reddy's (4) eca (1) EIR (1) Eli Lilly (1) ema (12) EU (9) FDA (70) FDA Guide (18) FEB17 (15) Genaral (1) General Health (2) GMP (1) GMP News (36) gsk (2) GuidelineEU (10) GuidelinesG (5) GuidelineW (2) GV/0117/001 (1) GVAuthors (3) Health (4) HOSPIRA (1) ICH (3) ICHGuide (3) import alert (1) India (1) ISPE (1) James Bullock (1) JAN17 (23) Jul17 (8) July17 (1) Jun17 (4) Lupin (2) Mahender (39) MAR17 (13) Mar18 (7) May17 (10) MHRA (3) MHRA guide (1) Mumbai (1) Mylan (4) Natco (1) News (55) Non Complinaces (1) Nov16 (5) Novartis (1) oct (1) Oct16 (10) OCT17 (1) PDA (1) Personnel (1) pfizer (1) pics (8) Picsguide (2) QbD (1) Quality Docs (1) RCA (1) Recall (1) safety (1) Sanjeev Kumar Singh (4) Sanofi (1) Sep16 (6) Siegfried Schmitt (2) SUN (1) TGA (3) TOP 10 PHARMA (1) USP (2) Validation (3) Warning Letters (43) WHO (6) zika (1)

    Sponsors

    Theme Support