ABRX: No big problems

1): These 27 adverse drug experiences (ADEs) reported to your firm between 1/4/02 and 1/16/04, were never reported to the FDA.

2): After announcing several product recalls earlier this year due to various improper laboratory practices and noncompliance with standard operating procedures, Able notified the FDA and began conducting an internal review of its operating practices, as initially announced in its quarterly report on Form 10-Q for the quarter ended March 31, 2005. Working with internal management resources, outside consultants and the FDA, the Company identified apparent departures from standard operating procedures with respect to certain laboratory testing practices. As a result of these observations, the Company recently suspended shipment of its products.

The bottomline is:
for problem 1, no people die because of their drug and every drug has side effects.
for problem 2, this one can be fixed after they change the procedures.

The only problem remains are:
What is the cost of these product recalls ?
How long will it take for them to return to normal ?


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The press make it seem as if the Stroke victim was recent. This letter is over a year old... What is with this BS???

I bought @ 3.65 ACH

CERTIFIED MAIL RETURN
RECEIPT REQUESTED

April 19, 2004

Mr. Jay Wadekar
President and CEO
Able Laboratories Inc.
5 & 6 Hollywood Ct.
South Plainfield, NJ 07080-4204

File # 04-NWJ-09

Dear Mr. Wadekar:

During the period of January 15, 2004 through February 4, 2004 Investigator Margaret Sands from the U.S. Food and Drug Administration (FDA) New Jersey District Office conducted an inspection of your drug manufacturing facility at the above referenced address to determine your firm抯 compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Title 21, Code of Federal Regulations, Part 314.80, 314.98 and Section 505(k) of the Federal Food, Drug and Cosmetic Act (the Act). Based on our review of the inspection report, we concluded that your firm violated Section 301(e) of the Act because it failed to comply with 21 CFR 314.80 and Section 505(k)(1) of the Act. Section 505(k)(1) requires an applicant to establish and maintain records, and report data relating to clinical experience and other data or information for drugs for which an approved application is in effect.

Deviations from 21 CFR 314.80 include the following:

1. Failure to submit to FDA 27 adverse drug experience reports received by your firm, for drug applications owned by your firm, as required in 21 CFR 314.80(c). These reports include, but are not limited to, the following:

COMPLAINT DATE PRODUCT ANDA# EVENT
C02C002 3/4/02 Lithium Caps 76-121 Trouble concentrating
C02C003 3/6/02 Lithium Caps 76-l 21 Irritable
C02T062 10/24/02 Lithium Caps 76-121 Chest pains, rash,difficulty breathing
C02T001 1/4/02 Methylphenidate 40404 Trouble functioning,Tablets sedation
C02C007 11/13/02 Phentermine Caps 40-403 Caused minor strokes, admitted to ER
C03T014 2/4/03 Carisoprodol 40-421 Diarrhea, headache
C03C029 4/8/03 Lithium Caps 76-121 Elevated blood levels
C03T080 1/22/03 Tramadol Tabs 75-963 Loss of taste


These 27 adverse drug experiences (ADEs) reported to your firm between 1/4/02 and 1/16/04, were never reported to the FDA. One of these complaints was by a patient taking Phentermine (Complaint C02C007). The patient was taken to an emergency room for a possible ?.. left midbrain or pontine infarct.?Furthermore, your Vice President of Quality/Regulatory Affairs, Mr. Shashi Shah, told our investigator that your firm had never submitted any ADE reports to FDA.

All 27 referenced ADEs that you failed to submit to the FDA are regulated under 21 CFR 314.80. In addition to the 15 day submission of serious and unexpected ADEs to the FDA, 21 CFR 314.80 also requires the periodic reporting of all serious and expected ADEs as well as ail non-serious ADEs. These periodic reports are required to be submitted quarterly for the first 3 years after a new drug approval and annually there after. You also have no record of submitting periodic reports to the FDA.

2. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of Postmarketing Adverse Drug Experiences to FDA, as required by 21 CFR 314.80.

Your firm has not developed adequate written procedures for the surveillance, receipt, evaluation, and reporting of Postmarketing Adverse Drug Experiences to the FDA. Our review of your internal control documents demonstrates this fact by the following examples:

Sincerely,

/s/

Diana Amador-Toro for Douglas I. Ellsworth
District Director
New Jersey District

所有跟帖： 

• 老大，那我明天可要冲进去抄低了 -stealth- ♂ (23 bytes) () 05/24/2005 postreply 23:24:52